Manage the execution of the assigned clinical study (ies) from initiation through to closeout. Ensure that clinical study management and project deliverables are on time and is in accordance with standard operating procedures (SOPs), policies and practices.
To provide project related support and assistance across multiple projects, sites and teams and review the structured clinical data output with access to medical charts.
To ensure the work is conducted as per SOPs, Policies and Good clinical practice’s and applicable regulatory requirements.
Adherence to protocol, overall completeness, and readiness of the supplied patient information to the next level of patient review and follow the metrics and timelines.
Facilitate efficient and effective review of Site Visit Reports and assure consistent standards of implementation for quality to meet or exceed quality standards.
Ensure subject safety, data integrity, escalation of issues and timely and responsive feedback in compliance with IQVIA SOPs, International Conference on Harmonisation - Good Clinical Practice (ICH GCP) guidelines, protocol requirements and regulatory compliance.
Develop and use of study management plans and / or risk-based monitoring specific tools and templates and / or other study specific plans to evaluate the quality and integrity of the study.
Support project management team to develop monitoring strategy including monitoring triggers / thresholds. Manage the operational insight of the assigned project(s) and complete the study / site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc.)
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